MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY CHARGER; VENTRICULAR (ASSISST) BYPASS

Model Number	1600US
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Product event summary: the battery charger passed external visual inspection, functional testing revealed status lights not working due to multiple damage internal components cause by inductors.The ready status light functioned as expected.Additionally, a component in the led charging circuit was damage resulting in the led in bay four (4) not working.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while a battery was successfully charging on a single port of the battery charger the status and ready lights would not light up.Product analysis indicated that an incorrect inductor was used in the assembly process.The battery charger was exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the battery charger was returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.Failure analysis of the returned battery charger revealed that the unit passed visual inspection.Functional testing revealed that an led status indicator was damaged.Supplemental testing revealed a damaged led.However, the "ready" led functioned as expected.It was determined that the battery charger was assembled with an incorrect inductor, damaging the led indicator circuit component.As a result, the "led status indicator light not working" event was confirmed; the "led ready indicator lights not working" event was not confirmed.The most likely root cause for the led status indicator lights not working can be attributed to improper assembly.An internal investigation was initiated to investigate battery chargers assembled with incorrect inductors.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY CHARGER
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7798075
• Report Number: 3007042319-2018-03910
• Device Sequence Number: 13846552
• Product Code: DSQ
• UDI-Device Identifier: 00888707000130
• UDI-Public: 00888707000130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/19/2018
• Device Model Number: 1600US
• Device Catalogue Number: 1600US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD
• Patient Age: 47 YR